Newborn MorbidityNCT06170892
Kangaroo Position in Preterm Newborn Infants Under Oxygen Therapy
A study testing Kangaroo method in people with Newborn Morbidity, run by Universidade Metodista de Piracicaba at 1 site in Brazil.
Trial summary
The kangaroo position, which is part of the Kangaroo Method strategy, is widely used in the Neonatal Intensive Care Unit and Neonatal Intermediate Care Units and aims to promote emotional bonding, cardiorespiratory, physiological and body temperature stability, in However, there is still little scientific evidence… Read more about this study
- Who is it for?
- Ages 2 to 28 days
- Conditions the study is for
- Newborn Morbidity
- What is being tested?
- Kangaroo method
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jan 2023to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- newborns with a gestational age of 28 to 36 weeks and 6 days,
- up to twenty-eight days of life;
- using supplemental circulating oxygen
Who cannot join
- neuromuscular disease;
- intracranial hypertension;
- intracranial hemorrhage;
- congenital heart disease
- pneumothorax;
- pneumatocele;
- active bleeding;
- mechanical ventilation
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Universidade do Estado do Pará
Belém, Pará, 66055-490
Rodrigo S Rocha, Phd, 91992340234, fisiorocha2000@yahoo.com.br
About this study
The kangaroo position, which is part of the Kangaroo Method strategy, is widely used in the Neonatal Intensive Care Unit and Neonatal Intermediate Care Units and aims to promote emotional bonding, cardiorespiratory, physiological and body temperature stability, in However, there is still little scientific evidence when it comes to newborns undergoing oxygen therapy. Identify, quantify and analyze the influence of the kangaroo position on the vital signs and respiratory comfort of preterm newborns using supplemental oxygen. To collect data, a physiotherapeutic assessment form suitable for clinical analysis was used. The newborns were placed in the kangaroo position in a single session, and the variables were identified before, during and after the application of the technique.
Read the detailed description
Due to the high rates of preterm newborns (PTNBs) admitted to the Neonatal Intensive Care Unit (NICU) requiring differentiated support, the Kangaroo Mother Care (MC) emerged with the intention of reducing neonatal morbidity and mortality and hospital costs. , leading to more humanized support.
MC was integrated into Humanized Care for low birth weight newborns, alleviating pain symptoms, improving the sleep-wake state, stimulating neuropsychomotor and sensory development, in addition to reducing stress.
Consisting of three stages, the first stage begins with the detection of a high-risk pregnancy until the birth of the child, and when necessary continues in the NICU or Conventional Neonatal Intermediate Care Unit (UCINCo) during the newborn's hospitalization period. born (NB), the second stage takes place at the Canguru Neonatal Intermediate Care Unit (UCINCa) where the person responsible, with the support of the multidisciplinary team, participates in most of the care carried out in the NB and finally the third stage, which covers the period of dehospitalization, as well as monitoring the development of the newborn and providing guidance to their family, monitoring occurs between the maternity ward where the patient was hospitalized and the Basic Health Unit (UBS).
Through a biopsychosocial intervention and based on the following pillars, the MC promotes welcoming newborns and their families, respect for individualities, promotion of skin-to-skin contact and involvement of the mother and father in the care of the newborn, promoting the encouraging breastfeeding and sensorimotor development, integrating the line of care for PTNBs and/or those with low birth weight (LBW), as well as their families. The kangaroo position (CP), which is part of the MC strategy, favors emotional bonding, cardiorespiratory, physiological and body temperature stability.
Newborns who need to remain hospitalized in the NICU or UCINCo may require oxygen therapy support, due to the possibility of presenting hypoxia, hyaline membrane disease, bronchopulmonary dysplasia, heart failure and pulmonary hypertension, among others.
It is extremely important to observe newborns who are using oxygen therapy, facilitating their weaning as early as possible, since, in high quantities and prolonged use, it can result in hyperoxia, especially in premature newborns, increasing risks of oxygen toxicity, reabsorption atelectasis, ventilation depression and retinopathy of prematurity13,15,16. From this perspective, this study aims to highlight the effects of the kangaroo position on the vital signs and respiratory comfort of premature and low birth weight newborns using oxygen therapy admitted to a Conventional Intermediate Neonatal Care Unit.
- Conditions
- Newborn Morbidity
- Being tested
- Kangaroo method
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kangaroo methodOther
The newborns were placed in the kangaroo position in a single session, and the variables were identified before, during and after the application of the technique.
| Study group | Role | What they receive |
|---|---|---|
| Kangaroo method | Experimental | The newborns were placed in the kangaroo position in a single session, and the variables were identified before, during and after the application of the technique. Receives: Other: Kangaroo method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate
heart rate assessment on the heart monitor
Measured: 1 year
respiratory frequency rate
assessment of respiratory rate in 60 seconds
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start1 Jan 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Newborn MorbidityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The newborns were placed in the kangaroo position in a single session, and the variables were identified before, during and after the application of the technique.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Metodista de Piracicaba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rodrigo Santiago Barbosa Rocha, Phd, Universidade Metodista de Piracicaba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06170892
- Sponsor's protocol ID
- 5.983.115
- Status last verified
- Dec 2023
- First submitted
- 3 Dec 2023
- Last updated
- 14 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Srinath BK, Shah J, Kumar P, Shah PS. Kangaroo care by fathers and mothers: comparison of physiological and stress responses in preterm infants. J Perinatol. 2016 May;36(5):401-4. doi: 10.1038/jp.2015.196. Epub 2015 Dec 17.
PubMed 26674998Dargahiyan Z, Ghasemi F, Karami K, Valizadeh F, Mohammadi R. A comparative study of the effects of Kangaroo care by mothers and maternal grandmothers on the vital signs of hospitalized preterm newborns: a randomized controlled clinical trial study. Trials. 2023 Apr 14;24(1):275. doi: 10.1186/s13063-023-07288-y.
PubMed 37059994El-Farrash RA, Shinkar DM, Ragab DA, Salem RM, Saad WE, Farag AS, Salama DH, Sakr MF. Longer duration of kangaroo care improves neurobehavioral performance and feeding in preterm infants: a randomized controlled trial. Pediatr Res. 2020 Mar;87(4):683-688. doi: 10.1038/s41390-019-0558-6. Epub 2019 Sep 7.
PubMed 31493775Ferber SG, Makhoul IR. Neurobehavioural assessment of skin-to-skin effects on reaction to pain in preterm infants: a randomized, controlled within-subject trial. Acta Paediatr. 2008 Feb;97(2):171-6. doi: 10.1111/j.1651-2227.2007.00607.x. Epub 2008 Jan 3.
PubMed 18177441Span LC, van Dokkum NH, Ravensbergen AG, Bos AF, Jaschke AC. Combining Kangaroo Care and Live-Performed Music Therapy: Effects on Physiological Stability and Neurological Functioning in Extremely and Very Preterm Infants. Int J Environ Res Public Health. 2021 Jun 18;18(12):6580. doi: 10.3390/ijerph18126580.
PubMed 34207310
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kangaroo Position in Preterm Newborn Infants Under Oxygen Therapy
- ClinicalTrials.gov ID
- NCT06170892
- Acronym / sponsor ID
- 5.983.115
- Conditions
- Newborn Morbidity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universidade Metodista de PiracicabaUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 14 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The kangaroo position, which is part of the Kangaroo Method strategy, is widely used in the Neonatal Intensive Care Unit and Neonatal Intermediate Care Units and aims to promote emotional bonding, cardiorespiratory, physiological and body temperature stability, in However, there is still little scientific evidence when it comes to newborns undergoing oxygen therapy. Identify, quantify and analyze the influence of the kangaroo position on the vital signs and respiratory comfort of preterm newborns using supplemental oxygen. To collect data, a physiotherapeutic assessment form suitable for clinical analysis was used. The newborns were placed in the kangaroo position in a single session, and the variables were identified before, during and after the application of the technique.
Detailed description
Due to the high rates of preterm newborns (PTNBs) admitted to the Neonatal Intensive Care Unit (NICU) requiring differentiated support, the Kangaroo Mother Care (MC) emerged with the intention of reducing neonatal morbidity and mortality and hospital costs. , leading to more humanized support.
MC was integrated into Humanized Care for low birth weight newborns, alleviating pain symptoms, improving the sleep-wake state, stimulating neuropsychomotor and sensory development, in addition to reducing stress.
Consisting of three stages, the first stage begins with the detection of a high-risk pregnancy until the birth of the child, and when necessary continues in the NICU or Conventional Neonatal Intermediate Care Unit (UCINCo) during the newborn's hospitalization period. born (NB), the second stage takes place at the Canguru Neonatal Intermediate Care Unit (UCINCa) where the person responsible, with the support of the multidisciplinary team, participates in most of the care carried out in the NB and finally the third stage, which covers the period of dehospitalization, as well as monitoring the development of the newborn and providing guidance to their family, monitoring occurs between the maternity ward where the patient was hospitalized and the Basic Health Unit (UBS).
Through a biopsychosocial intervention and based on the following pillars, the MC promotes welcoming newborns and their families, respect for individualities, promotion of skin-to-skin contact and involvement of the mother and father in the care of the newborn, promoting the encouraging breastfeeding and sensorimotor development, integrating the line of care for PTNBs and/or those with low birth weight (LBW), as well as their families. The kangaroo position (CP), which is part of the MC strategy, favors emotional bonding, cardiorespiratory, physiological and body temperature stability.
Newborns who need to remain hospitalized in the NICU or UCINCo may require oxygen therapy support, due to the possibility of presenting hypoxia, hyaline membrane disease, bronchopulmonary dysplasia, heart failure and pulmonary hypertension, among others.
It is extremely important to observe newborns who are using oxygen therapy, facilitating their weaning as early as possible, since, in high quantities and prolonged use, it can result in hyperoxia, especially in premature newborns, increasing risks of oxygen toxicity, reabsorption atelectasis, ventilation depression and retinopathy of prematurity13,15,16. From this perspective, this study aims to highlight the effects of the kangaroo position on the vital signs and respiratory comfort of premature and low birth weight newborns using oxygen therapy admitted to a Conventional Intermediate Neonatal Care Unit.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The newborns were placed in the kangaroo position in a single session, and the variables were identified before, during and after the application of the technique.
| Arm | Type | Receives |
|---|---|---|
| Kangaroo method | Experimental | Other: Kangaroo methodThe newborns were placed in the kangaroo position in a single session, and the variables were identified before, during and after the application of the technique. |
Who may qualify
- Ages
- 2 to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- newborns with a gestational age of 28 to 36 weeks and 6 days,
- up to twenty-eight days of life;
- using supplemental circulating oxygen
Key exclusion criteria (8 listed)
- neuromuscular disease;
- intracranial hypertension;
- intracranial hemorrhage;
- congenital heart disease
- pneumothorax;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kangaroo methodThe newborns were placed in the kangaroo position in a single session, and the variables were identified before, during and after the application of the technique. | Other | Kangaroo method |
Primary outcome
Heart rate
Time frame: 1 year
heart rate assessment on the heart monitor
respiratory frequency rate
Time frame: 1 year
assessment of respiratory rate in 60 seconds
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2023.
- Results publication: PubMed 26674998Srinath BK, Shah J, Kumar P, Shah PS. Kangaroo care by fathers and mothers: comparison of physiological and stress responses in preterm infants. J Perinatol. 2016 May;36(5):401-4. doi: 10.1038/jp.2015.196. Epub 2015 Dec 17.
- Results publication: PubMed 37059994Dargahiyan Z, Ghasemi F, Karami K, Valizadeh F, Mohammadi R. A comparative study of the effects of Kangaroo care by mothers and maternal grandmothers on the vital signs of hospitalized preterm newborns: a randomized controlled clinical trial study. Trials. 2023 Apr 14;24(1):275. doi: 10.1186/s13063-023-07288-y.
- Results publication: PubMed 31493775El-Farrash RA, Shinkar DM, Ragab DA, Salem RM, Saad WE, Farag AS, Salama DH, Sakr MF. Longer duration of kangaroo care improves neurobehavioral performance and feeding in preterm infants: a randomized controlled trial. Pediatr Res. 2020 Mar;87(4):683-688. doi: 10.1038/s41390-019-0558-6. Epub 2019 Sep 7.
- Results publication: PubMed 18177441Ferber SG, Makhoul IR. Neurobehavioural assessment of skin-to-skin effects on reaction to pain in preterm infants: a randomized, controlled within-subject trial. Acta Paediatr. 2008 Feb;97(2):171-6. doi: 10.1111/j.1651-2227.2007.00607.x. Epub 2008 Jan 3.
- Results publication: PubMed 34207310Span LC, van Dokkum NH, Ravensbergen AG, Bos AF, Jaschke AC. Combining Kangaroo Care and Live-Performed Music Therapy: Effects on Physiological Stability and Neurological Functioning in Extremely and Very Preterm Infants. Int J Environ Res Public Health. 2021 Jun 18;18(12):6580. doi: 10.3390/ijerph18126580.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kangaroo method in people with Newborn Morbidity, run by Universidade Metodista de Piracicaba at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06170892, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2023.